QMS overflow support Explained
Published on: 06/10/2026
The value of overflow support ultimately depends on how well the additional capacity is integrated into existing quality processes.
QMS Overflow
Advancing a Botanical Drug Product into Phase 2
Published on: 01/10/2026
Advancing a botanical-derived product into clinical development presents a distinctive quality and CMC challenge. Unlike a conventional synthetic drug substance, a botanical-derived product may originate from naturally variable material
Case Study: Advancing a Botanical-Derived Drug Product into Phase 2 Clinical Development
Dealing with audit deficiency remediation
Published on: 29/09/2026
Audit deficiency remediation is the process of identifying the underlying cause of a compliance gap, determining the actions required to correct it, and establishing objective evidence that the corrective actions have been implemented
Dealing with audit deficiency remediation
Achieving TGA medical device compliance
Published on: 25/09/2026
For manufacturers, this means integrating regulatory requirements into product development, quality management and operational decision-making.
Achieving TGA medical device compliance